Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach.
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Toupin-April Karine, Décary Simon, de Wit Maarten, Meara Alexa, Barton Jennifer L, Fraenkel Liana, Li Linda C, Brooks Peter, Shea Beverly, Stacey Dawn, Légaré France, Lydiatt Anne, Hofstetter Cathie, Proulx Laurie, Christensen Robin, Voshaar Marieke, Suarez-Almazor Maria E, Boonen Annelies, Meade Tanya, March Lyn, Jull Janet Elizabeth, Campbell Willemina, Alten Rieke, Morgan Esi M, Kelly Ayano, Kaufman Jessica, Hill Sophie, Maxwell Lara J, Guillemin Francis, Beaton Dorcas, El-Miedany Yasser, Mittoo Shikha, Westrich Robertson Tiffany, Bartlett Susan J, Singh Jasvinder A, Mannion Melissa, Nasef Samah Ismail, de Souza Savia, Boel Anne, Adebajo Adewale, Arnaud Laurent, Gill Tiffany K, Moholt Ellen, Burt Jennifer, Jayatilleke Arundathi, Hmamouchi Ihsane, Carrott David, Blanco Francisco J, Mather Kate, Maharaj Ajesh, Sharma Saurab, Caso Francesco, Fong Christopher, Fernandez Anthony P, Mackie Sarah, Nikiphorou Elena, Jones Allyson, Greer-Smith Regina, Sloan Victor S, Akpabio Akpabio, Strand Vibeke, Umaefulam Valerie, Monti Sara, Melburn Charmaine, Abaza Nouran, Schultz Kirsten, Stones Simon, Kiwalkar Sonam, Srinivasalu Hemalatha, Constien Deb, King Lauren K, Tugwell Peter
Аннотация
METHODS: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set.
RESULTS: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention.
CONCLUSION: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set.
CLINICAL SIGNIFICANCE: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.